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3 Commercial Labs Fighting Zika Threat to Bet On

The World Health Organization’s (WHO) announcement regarding the Zika virus scaling to a Public Health Emergency of International Concern status has been the talk of the nation for long. Zika, like many other mosquito borne diseases, took the shape of an endemic in many densely inhabited nations. However, things took a serious turn in the U.S.when a growing number of cases started cropping up.

The Outbreak at a Glance

Zika virus infections are spread through Aedes aegypti mosquito bites. Also, the disease can be transmitted from mother to fetus during pregnancy and through sexual transmission. People infected with Zika may have symptoms such as mild fever, rash, muscle and joint pains or conjunctivitis. The infection may cause microcephaly and other birth defects during pregnancy. The Zika virus disease is believed to have taken a pandemic form, quite similar to AIDS.

Since 2015, 70 countries and territories recorded evidence of vector-borne Zika virus transmissions. As of Jul 2016, the U.S. Department of Health and Human Services has confirmed a number of such cases with major outbreaks in the state of Florida. According to the Centers for Disease Control and Prevention (CDC), the total number of cases registered (locally acquired and travel-associated) in the U.S. and the U.S. territories were 20,870 as of Sep 14, 2016. Out of these, 3,176 cases were solely within the U.S. Among the 50 states, 639 identified cases were in Florida, with 43 of those cases locally acquired.

Initiatives

CDC has its own set of criteria to accurately detect Zika virus infection. Its Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) gained the U.S. FDA’s authorization for emergency use on Feb 26, 2016, which was reissued on Jun 29, 2016, for the detection of Zika virus IgM antibodies in serum or cerebrospinal fluid (collected alongside a patient-matched serum specimen).

This apart, there are drug stocks which are actively working on developing vaccines, and also a number of leading commercial laboratories in the U.S. that are working on tests to diagnose Zika infections in a comprehensive manner. According to the U.S. Association of Public Health Laboratories, the commercial laboratories can play a pivotal role in public health response to emerging infectious diseases like Zika. These organizations have the expertise, scale and logistics support, as well as access to healthcare providers and patients that support and extend the capabilities of the nation's public health laboratories.

3 Stocks in Focus

Let us take a look at some of the commercial lab stocks that are actively combating and restricting this pandemic. These stocks, while still at their pipeline of success related to Zika, should be considered by investors for handsome returns.

On Sep 21, this leading provider of diagnostic information and infectious disease testing services announced the launch of Zika Antibody Test Service based on CDC’s Zika MAC-ELISA. Notably, Quest Diagnostics was the first commercial laboratory to receive FDA emergency use authorization for a Zika test for the qualitative detection of RNA from Zika virus in human serum specimens. On Sep 6, the company extended this molecular assay with the introduction of an RT-PCR Zika test service for the qualitative detection in serum and paired urine specimens.

With the new test service, Quest Diagnostics offers access to Zika virus antibody and molecular laboratory test services in the U.S. as well as Puerto Rico and other U.S. territories. Healthcare providers in other countries may also refer specimens for Zika testing to Quest Diagnostics. Molecular RT-PCR tests detect the presence of Zika virus RNA and is most useful up to 14 days as the symptoms start, depending on sample type and other factors, compared to Zika MAC-ELISA which is useful two to 12 weeks following the onset of symptoms.

On Sep 8, Hologic announced that the FDA extended the emergency use authorization (EUA) for the company's Aptima Zika virus diagnostic assay to be used with urine samples (collected alongside patient-matched serum or plasma specimens). Hologic's Zika virus assay was authorized for emergency use with serum and plasma (blood) samples in Jun 2016. Its new use with urine samples lengthens the time period during which patients can be tested for Zika from seven days to 14 days following symptoms, as recommended CDC.

The Aptima Zika virus assay by Hologic is a molecular diagnostic tool for comprehensive detection of Zika virus RNA (Ribonucleic acid) in human specimens. RNA is a type of molecule which has substantial genetic information. The assay or trial runs on Hologic’s Panther System which is a market leading integrated platform that entirely automates all aspects of nucleic acid amplification testing. This platform reduces time, labor and energy for manual errors. The Aptima Zika Virus assay has not received any FDA approval for commercial use and has only been authorized for Zika virus detection in in-vitro diagnostic tests. The assay is available for use in 50 states, Puerto Rico and the U.S. territories.

On Jun 6, LabCorp announced the availability of Zika virus test using the RealStar Zika Virus RT-PCR Kit U.S. from altona Diagnostics GmbH. The assay has received Emergency Use Authorization (EUA) from the FDA for the qualitative detection of Zika virus RNA in serum or urine. RT-PCR tests for Zika virus can be used as a primary test only up to the first 7 to 14 days after the onset of symptoms, depending on the sample type tested

As per Market Research Media report, the global Zika virus preparedness market is expected to reach $4 billion by 2022 and grow at CAGR 11% in the period 2017--2022. The above stocks are working hard to offer physicians and patients easy access to Zika infection testing services and respond to the alarming number of cases being registered in recent times.

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